Single operator device for delivering an ocular implant

ABSTRACT

An ocular implant delivery system is provided with a number of features. In some embodiments, the delivery system comprises a rotation mechanism configured to rotate and orient a cannula of the system, and an advancement mechanism configured to advance and retract an ocular implant through the delivery system and into an eye of a patient. In some embodiments, the cannula is sized and configured to be inserted into Schlemm&#39;s canal of the eye. The ocular implant is configured to maintain its orientation within the delivery system as the cannula is rotated. In some embodiments, the ocular implant automatically disengages the delivery system when it is advanced beyond a distal tip of the delivery system. Methods of implanting an ocular implant are also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.12/833,852, filed Jul. 9, 2010, now U.S. Pat. No. 9,693,899; whichapplication claims the benefit under 35 U.S.C. 119 of U.S. ProvisionalPatent Application No. 61/224,156, filed Jul. 9, 2009, titled “SingleOperator Device for Delivering an Ocular Implant”. These applicationsare herein incorporated by reference in their entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to devices that are implantedwithin the eye and delivery systems for such devices. More particularly,the present invention relates to delivery system for devices thatfacilitate the transfer of fluid from within one area of the eye toanother area of the eye.

BACKGROUND OF THE INVENTION

According to a draft report by The National Eye Institute (NEI) at TheUnited States National Institutes of Health (NIH), glaucoma is now theleading cause of irreversible blindness worldwide and the second leadingcause of blindness, behind cataract, in the world. Thus, the NEI draftreport concludes, “it is critical that significant emphasis andresources continue to be devoted to determining the pathophysiology andmanagement of this disease.” Glaucoma researchers have found a strongcorrelation between high intraocular pressure and glaucoma. For thisreason, eye care professionals routinely screen patients for glaucoma bymeasuring intraocular pressure using a device known as a tonometer. Manymodem tonometers make this measurement by blowing a sudden puff of airagainst the outer surface of the eye.

The eye can be conceptualized as a ball filled with fluid. There are twotypes of fluid inside the eye. The cavity behind the lens is filled witha viscous fluid known as vitreous humor. The cavities in front of thelens are filled with a fluid know as aqueous humor. Whenever a personviews an object, he or she is viewing that object through both thevitreous humor and the aqueous humor.

Whenever a person views an object, he or she is also viewing that objectthrough the cornea and the lens of the eye. In order to be transparent,the cornea and the lens can include no blood vessels. Accordingly, noblood flows through the cornea and the lens to provide nutrition tothese tissues and to remove wastes from these tissues. Instead, thesefunctions are performed by the aqueous humor. A continuous flow ofaqueous humor through the eye provides nutrition to portions of the eye(e.g., the cornea and the lens) that have no blood vessels. This flow ofaqueous humor also removes waste from these tissues.

Aqueous humor is produced by an organ known as the ciliary body. Theciliary body includes epithelial cells that continuously secrete aqueoushumor. In a healthy eye, a stream of aqueous humor flows out of theanterior chamber of the eye through the trabecular meshwork and intoSchlemm's canal as new aqueous humor is secreted by the epithelial cellsof the ciliary body. This excess aqueous humor enters the venous bloodstream from Schlemm's canal and is carried along with the venous bloodleaving the eye.

When the natural drainage mechanisms of the eye stop functioningproperly, the pressure inside the eye begins to rise. Researchers havetheorized prolonged exposure to high intraocular pressure causes damageto the optic nerve that transmits sensory information from the eye tothe brain. This damage to the optic nerve results in loss of peripheralvision. As glaucoma progresses, more and more of the visual field islost until the patient is completely blind.

In addition to drug treatments, a variety of surgical treatments forglaucoma have been performed. For example, shunts were implanted todirect aqueous humor from the anterior chamber to the extraocular vein(Lee and Scheppens, “Aqueous-venous shunt and intraocular pressure,”Investigative Ophthalmology (February 1966)). Other early glaucomatreatment implants led from the anterior chamber to a sub-conjunctivalbleb (e.g., U.S. Pat. No. 4,968,296 and U.S. Pat. No. 5,180,362). Stillothers were shunts leading from the anterior chamber to a point justinside Schlemm's canal (Spiegel et al., “Schlemm's canal implant: a newmethod to lower intraocular pressure in patients with POAG?” OphthalmicSurgery and Lasers (June 1999); U.S. Pat. No. 6,450,984; U.S. Pat. No.6,450,984). Delivery and deployment systems for some glaucoma implantsare described, e.g., in US 2007/0191863 and US 2007/0010827. Surgicaldevices for accessing Schlemm's canal are described, e.g., in US2007/0073275 and US 2006/0149194.

SUMMARY OF THE INVENTION

In one embodiment, an ocular implant delivery system comprises ahousing, a cannula coupled to the housing, the cannula sized andconfigured for insertion into Schlemm's canal of a human eye, a deliverymechanism disposed on the housing, the delivery mechanism configured toadvance and retract an ocular implant within the cannula, and anorientation mechanism disposed on the housing, the orientation mechanismconfigured to control rotation of the cannula, wherein the ocularimplant maintains its orientation with respect to the cannula when thecannula is rotated.

In some embodiments, the ocular implant delivery system furthercomprises a push tube slidably disposed within the cannula and coupledto the delivery mechanism. The ocular implant can be coupled to a distalportion of the push tube. In some embodiments, an interlocking finger ofthe implant is coupled to a finger receptacle on the push tube.

In another embodiment, the ocular implant delivery system furthercomprises a core shaft disposed within the ocular implant. The coreshaft or core cable can be configured to align with an interior diameterof the ocular implant so as to prevent any sharp edges or holes of theimplant from engaging tissue during implantation.

In one embodiment of the delivery system, the relative locations of thedelivery mechanism and the orientation mechanism on the housing allowcontrol over advancement and retraction of the ocular implant androtation of the cannula with a single hand.

In another embodiment, the ocular implant is configured to automaticallydisengage from the ocular implant delivery system when it is advancedbeyond a distal tip of the cannula. In some embodiments, the ocularimplant is pre-biased to assume an expanded configuration. When theimplant is advanced beyond the tip of the cannula, the implant canexpand so as to disengage the delivery system (e.g., disengage a pushtube).

In one embodiment, the ocular implant delivery system further comprisesa core cable having a locking key, the locking key being configured toengage the ocular implant.

A method of delivering an implant into an eye of a patient is provided,comprising inserting a delivery device into the eye, advancing theimplant into the eye through the delivery device, and expanding theimplant to disengage the implant from the delivery device.

In some embodiments, the inserting step further comprises inserting acannula into Schlemm's canal of the eye.

Another embodiment of the method further comprises the step of adjustingan orientation of the cannula with an orientation mechanism to align thecannula with a curvature of Schlemm's canal.

In some embodiments of the method, the advancing step and the adjustingstep are achieved with a single-hand of a user.

The advancing step of the method can further comprise advancing theimplant with a wheel disposed on the delivery device. In anotherembodiment, the advancing step further comprises advancing the implantinto the eye past a distal tip of the delivery device. In an additionalembodiment, the implant automatically expands to disengage itself fromthe delivery device when it is advanced past the distal tip of thedelivery device.

In some embodiments, the expanding step further comprises expanding theimplant to disengage an interlocking component of the implant from aninterlocking component of the delivery device. The interlockingcomponent of the delivery device can be an interlocking component of apush tube, for example. In another embodiment, the interlockingcomponent of the delivery device can be an interlocking component of acore cable.

In some embodiments of the method, the advancing step further comprisesadvancing the implant into the eye with a push tube.

Alternatively, the advancing step can further comprise advancing theimplant into the eye with a core cable. In one embodiment, the methodcan further comprise removing the core cable from the implant afterexpanding the implant.

In another embodiment, the implant is inserted into a suprachoroidalspace.

Another method of implanting an ocular implant into Schlemm's canal ofan eye is provided, comprising rotating an orientation mechanism of adelivery device to align a cannula with Schlemm's canal, advancing thecannula through a corneal incision and into the eye, piercing Schlemm'scanal with the cannula, controlling an advancement mechanism of thedelivery system with a first hand to advance the ocular implant from thedelivery system into Schlemm's canal, holding a gonioscope with a secondhand during the controlling step to visualize implantation of the ocularimplant into Schlemm's canal, and automatically disengaging the ocularimplant from the delivery system when the ocular implant is advancedbeyond a distal tip of the cannula.

In some embodiments, the method further comprises expanding the ocularimplant in the eye to disengage the ocular implant from the deliverysystem.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a schematic drawing of a human eye.

FIG. 2 is a close-up view of the eye showing Schlemm's canal.

FIG. 3 is a delivery device for implanting an ocular implant in an eye.

FIGS. 4 and 5 are close-up views of a portion of the delivery device.

FIG. 6 is a cutaway side view of the delivery device.

FIG. 7 is a close-up cutaway side view of the delivery device.

FIG. 8 is an exploded view showing the internal features of the deliverydevice.

FIGS. 9, 10 and 11 are close-up views of some internal features of thedelivery device.

FIGS. 12 and 13 are cutaway side views of the delivery device.

FIG. 14 is a close-up cutaway side view of a portion of the deliverydevice.

FIGS. 15, 16 and 17 illustrate one embodiment of detaching an ocularimplant from the delivery device.

FIGS. 18 and 19 illustrate another embodiment of detaching an ocularimplant from the delivery device.

FIGS. 20, 21 and 22 illustrate a method for implanting an ocular devicein an eye of a patient.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description should be read with reference to thedrawings, in which like elements in different drawings are numberedidentically. The drawings, which are not necessarily to scale, depictexemplary embodiments and are not intended to limit the scope of theinvention. Examples of constructions, materials, dimensions, andmanufacturing processes are provided for selected elements. All otherelements employ that which is known to those of skill in the field ofthe invention. Those skilled in the art will recognize that many of theexamples provided have suitable alternatives that can be utilized.

The devices, systems, and methods described herein may aid in thetreatment of glaucoma. The implantable ocular devices described hereinmay be inserted into Schlemm's canal, the trabecular meshwork, thesuprachoroidal space, and/or the anterior chamber of the eye tofacilitate the outflow of aqueous humor from the anterior chamber. Whenin place within the eye, the implantable devices can support trabecularmeshwork tissue and/or Schlemm's canal tissue, and can provide forimproved communication between the anterior chamber and Schlemm's canal(via the trabecular meshwork), between pockets or compartments alongSchlemm's canal, and/or the suprachoroidal space.

The systems described herein may include delivery devices for deliveringimplantable devices into Schlemm's canal, the trabecular meshwork, thesuprachoroidal space, and/or the anterior chamber of the eye. Thedelivery devices described herein may be configured to advance, retract,and deploy the implantable device precisely and predictably by a singlephysician or surgeon using the motion of a single finger. The deliverydevice may selectively engage the implantable device allowing the deviceto be advanced and retracted before implantation within the eye. Thedelivery devices described herein may also be configured to rotate abent portion of the delivery device to align with the curvature of theiris of the eye.

FIG. 1 is a schematic view showing a portion of an eye 20. A reflectionon the outer surface of the cornea 22 of the eye is visible in FIG. 1.Cornea 22 encloses an anterior chamber 24 of eye. The iris 26 of the eyeis visible through the cornea and anterior chamber. Anterior chamber 24is filled with aqueous humor which helps maintain the generallyhemispherical shape of the cornea. The structures that drain aqueoushumor from anterior chamber 24 include Schlemm's canal 30 and a largenumber of veins 28.

In FIG. 1, Schlemm's canal 30 can be seen encircling iris 26. Aqueoushumor exits anterior chamber 24 and enters Schlemm's canal 30 by flowingthrough a trabecular mesh 32. Aqueous humor exits Schlemm's canal 30 byflowing through a number of outlets called collector channels 40. Afterleaving Schlemm's canal 30, aqueous humor travels through veins 28 andis absorbed into the blood stream.

FIG. 2 is an enlarged schematic view of a portion of eye 20 shown in theprevious figure. The flow of aqueous humor in eye 20 is illustratedusing arrows in FIG. 2. In FIG. 2, aqueous humor flowing throughtrabecular mesh 32 and into Schlemm's canal 30 is represented by anumber of lateral flow arrows 34. The flow of aqueous humor along thelength of Schlemm's canal is illustrated using a number of axial flowarrows 36.

FIG. 3 illustrates a single operator delivery device 100 configured todeliver an ocular implant into the eye of a patient, such as intoSchlemm's canal, the trabecular meshwork, the suprachoroidal space,and/or the anterior chamber of the eye. The ocular implant to beimplanted can include any ocular implant described in U.S. applicationSer. Nos. 11/860,318, 11/943,289, 12/236,254, 12/398,847, and U.S.Provisional Patent Appln. Nos. 61/033,746, 61/120,222, and 61/120,295.

Referring to FIG. 3, delivery device 100 can include housing 102,rotatable sleeve 104, tracking wheel 106, cannula 108, and end cap 110.The delivery device shown in FIG. 3 is configured to be gripped with onehand while providing control of rotation and orientation of the cannula(via the rotatable sleeve 104) in addition to control over advancement,retraction, and deployment of the ocular implant (via the tracking wheel106), all while gripping the delivery device with the same hand. Ingeneral, the tracking wheel is a delivery mechanism configured foradvancement and retraction of the ocular implant and the rotatablesleeve is an orientation mechanism configured to control rotation andorientation of the cannula. The housing of delivery device 100—inparticular, the relative location of the movable control elements withinthe housing—results in an ideal ergonomic relationship of thefinger-operated control elements relative to the hand-stabilizedhousing. This design provides a configuration that will allow a user,such as a physician, to stabilize and orient the delivery device whilesimultaneously allowing the middle or index finger to move independentlyand perform the implantation of an ocular implant. This one-handedoperation leaves the physician's other hand free for other uses, such asholding a gonioscope.

FIGS. 4-5 show a close-up view of rotatable sleeve 104 and cannula 108.In some embodiments, the cannula can have a curved or bent distalportion 114 configured to aid with implantation of an ocular implantinto the eye, such as into Schlemm's canal. The bent distal portion ofthe cannula may have a pre-formed bend or curvature that is sized andconfigured to align with and be implanted in the natural curvature ofSchlemm's canal. The cannula may also have a sharpened or beveled tip,for example, to cut into and through tissue. As shown, cannula can mountto a hub 112. The hub can attach to the rotatable sleeve in a number ofways, such as by a pin 116 or by an adhesive. By coupling the rotatablesleeve 104 to the cannula 108 and hub 112, rotation of the rotatablesleeve (such as by a physician) can change the orientation of thecannula with respect to the housing 102. For example, FIG. 4 shows thecannula in a first orientation, and FIG. 5 shows the cannula in a secondorientation after rotation of the rotatable sleeve. The rotatable sleeve104 may also include gripping features, such as grooves (as shown), arubber coating, or other frictional surfaces on the rotatable sleeve.

During implantation of an ocular implant, correct alignment between thecannula and iris is necessary to ensure that the ocular implant isadvanced at the correct trajectory relative to Schlemm's canal or otheranatomy in the eye into which the ocular implant is to be implanted.Changing the orientation of the cannula with respect to the housingallows the delivery device 100 to be adjusted to accommodate individualanatomical variables, individual physician holding position preferences,and right/left handed users. The delivery device is configured in amanner that keeps the ocular implant aligned within the delivery deviceduring rotation. All components are keyed together to ensure that theimplant and cannula rotate as a single body while simultaneouslyallowing linear movement (i.e., advancement and retraction) of theocular implant. For example, in some embodiments of an ocular implant,certain features of the implant, such as openings in the implant, areconfigured to be aligned with specific anatomy, such as collectorchannels of Schlemm's canal. Since the delivery device described hereinkeeps the ocular implant aligned with a predetermined curvature of thecannula, a physician can ensure the proper orientation of the implantonce it's been delivered to Schlemm's canal.

FIG. 6 is a cutaway view of the delivery device 100 showing the device'sinternal features, including tracking wheel 106, idler gear 118, androtating rack gear 120. Tracking wheel 106 and idler gear 118 arerotatably mounted to the housing 102. Gears on the tracking wheel engagewith gears on the idler gear 118, which in turn engage with gears on therotating rack gear 120 to move the rack gear proximally and distallywithin the delivery device. The idler gear 118 is included in the deviceso that rotation of the tracking wheel 106 in the distal direction willcause the rack gear to move distally, and rotation of the tracking wheelin the proximal direction will cause the rack gear to move proximally.In addition, the rotating rack gear 120 is configured to rotate withrotatable sleeve 104 while maintaining the ability to move linearly inthe distal and proximal directions before, during, and after rotation.

FIG. 7 is a close-up view of the internal features of the deliverydevice near the rotatable sleeve 104, including hub 112, pin 116, ocularimplant 122, push tube 124, and O-ring 126. The ocular implant and pushtube can be any ocular implant and push tube as described in the USpatent applications and Provisional patent applications reference above.As shown in FIG. 7, the ocular implant can be positioned partiallywithin cannula 108 and can abut push tube 124 in the delivery device.The O-ring can provide tension and resistance to the rotatable sleevefor tactile feedback during rotation and can prevent the sleeve frombeing moved from the desired orientation.

FIGS. 8-11 are exploded views of the internal features of deliverydevice 100, including housing 102, tracking wheel 106, cannula 108, endcap 110, hub 112, idler gear 118, rotating rack gear 120, push tube 124,slot 128, transport tube 130, interlocking finger connector 132, fingerreceptacle 134, and core cable or core shaft 136. As shown in FIG. 8,transport tube 130 is connected to hub 112 and is sized to slidablycarry an ocular implant and push tube 124 therein. A proximal portion ofthe transport tube (as shown in FIG. 9) can include a hexagonal sleevesized to fit within a hexagonal through-hole in the rotating rack gear120 (as shown in FIG. 11).

As described herein and in the above referenced applications, push tube124 and the ocular implant can be sized and configured to slide withintransport tube 130 and a cannula. The push tube 124 can have a diametercorresponding to the diameter of the ocular implant, so that distalmovement of the push tube can push against and cause distal movement ofthe ocular implant within the delivery system and into the patient.

Furthermore, the delivery device can also include a core cable 136 sizedto slide within the ocular implant and push tube 124. Referring to FIGS.8 and 11, the core cable 136 can be coupled to the rotating rack gear120. As described in the above referenced applications, the core cablecan be positioned within an internal diameter of the ocular implantduring delivery of the implant so as to block and prevent any sharpedges or holes in the implant (such as the edges of fluid inlets andoutlets in the implant) from cutting or damaging tissue within thepatient during implantation. Additionally, the core can have a distalradius adapted to dilate Schlemm's canal as the implant is inserted intothe patient.

As shown in FIGS. 10-11, a proximal portion of the core cable caninclude interlocking finger receptacles 134 adapted to engage and joininterlocking fingers 132 on a proximal portion of the push tube. Theinterlocking fingers 132 can be pre-biased to assume an expanded oroutward configuration. For example, the interlocking fingers 132 can beformed from stainless steel or from a shape memory material such asNitinol. In some embodiments, the interlocking finger receptacles andthe interlocking fingers are cut from hypotubes having the samediameter. When the fingers are compressed, such as within transport tube130, they can engage the interlocking finger receptacles to join thepush tube and core cable together, and allow the push tube and corecable to move together through the transport tube 130 and deliverysystem as the rotating rack gear is moved distally and proximally.

FIGS. 12-13 illustrate how rotation of the tracking wheel 106 causes themovement of idler gear 118, rotating rack gear 120, ocular implant, pushtube 124, and core cable 136, thereby enabling one-handed operationthrough one-fingered advancement of the implant, release of the implantand retraction of the delivery mechanism. In FIG. 12, delivery device100 is shown prior to deployment of the ocular implant into the patient,with rotating rack gear 120 positioned proximally within slot 128 inhousing 102. FIG. 13 shows the delivery device fully deployed, with therotating rack gear positioned distally in slot 128 and touching hub 112.To move the rotating rack gear 120 from the proximal position shown inFIG. 12, to the distal position shown in FIG. 13, the tracking wheel 106can be rotated distally (e.g., in a counter-clockwise direction as shownby the arrows in FIG. 13), which causes idler gear 118 to rotate in aproximal direction, which in turn causes the rotating rack gear 120 tomove distally towards hub 112. Similarly, the rotating rack gear can bereturned to the proximal position within housing 102 by rotatingtracking wheel 106 in a proximal direction. In another embodiment, theidler gear can be eliminated from the delivery device, which would causedistal movement of the tracking wheel to move the rack gear proximally.

As the rotating rack gear 120 moves distally from the proximal positionin FIG. 12 to the distal position in FIG. 13, the rack gear causes pushtube 124, core cable 136, and the ocular implant (not shown) to movedistally within transport tube 130. When the rack gear is in the distalposition as shown in FIG. 13, the ocular implant is pushed completelyout of cannula 108 and into the patient. In some embodiments, the rackgear need not be fully advanced in the distal-most position to push theimplant out of the cannula.

Additionally, when the rack gear is in the distal-most position, theinterlocking fingers 132 (show in FIG. 14) of the push tube 124 and theinterlocking finger receptacles 134 (show in FIG. 14) of the core cable136 are positioned in an opening 138 in hub 112, as shown in FIG. 14.The opening 138 can have a larger inner diameter than the transport tube130. The transport tube 130 can terminate at the opening 138, so whenthe interlocking fingers enter the opening and are no longer constrainedby the inner walls of the transport tube, the interlocking fingers 132are allowed to automatically expand outward to assume their pre-biasedconfiguration, thereby disengaging the push tube 124 from the fingerreceptacles 134 of the core cable 136. With the core cable detached fromthe push tube, proximal movement of the rack gear (such as by rotatingthe tracking wheel in a proximal direction) can remove the core cableproximally from the push tube and ocular implant, thereby removing thecore cable from the implant and leaving the implant in the patient. Thepush tube is allowed to remain at the distal-most position to abut theocular implant and keep the implant in place as the core cable isremoved.

It should be understood that the advancement and retraction of theocular implant are not limited to the tracking wheel described herein.For example, in some embodiments, the housing may include buttons and amotor for electronically driving the wheel to advance and retract theimplant.

FIGS. 15-17 illustrate an embodiment of a device and method forselectively coupling an ocular implant 122 to a push tube 124 in adelivery device 100. FIG. 15 is a top down view of push tube 124 andocular implant 122 positioned within cannula 108 of delivery device 100.The push tube and ocular implant can include an interlocking component140, similar to the interlocking fingers and interlocking fingerreceptacles described above. For example, the push tube may include aninterlocking finger and the ocular implant may include an interlockingfinger receptacle, or vice versa. Any variety of interlocking shapes maybe used. FIG. 16 is a side view of the push tube and ocular implantshown in FIG. 15. FIG. 16 shows the ocular implant further comprising aslit or plurality of slits 142. The ocular implant can be pre-biased toassume an expanded configuration. When the implant is compressed, suchas within the cannula or the transport tube described above, theinterlocking component 140 will compress and cause the implant to engageand lock with the push tube. However, when the ocular implant is pusheddistally beyond the distal tip of the cannula 108, as shown in FIG. 17,the implant can assume its pre-biased configuration, causing the implantto automatically expand along the slits and detach from the push tube tobe released in the patient. The expanded portion of the implant alsoprovides for a larger opening to prevent clogging when implanted insidea patient.

FIGS. 18-19 illustrate an alternative embodiment of the delivery system100 that does not include a push tube, but rather uses a locking key 144coupled to the core cable 136 to advance, retract, and deliver theocular implant into a patient. As shown in FIG. 18, core cable 136 canbe disposed within the ocular implant 122 and cannula 108 of deliverysystem 100. Locking key 144 can be disposed on the core cable and canengage window 146 in the ocular implant. As described above, the implantcan be pre-biased to assume an expanded configuration when the implantis not constrained (e.g., such as when the implant is not constrainedwithin a cannula). When the implant is compressed, such as within thecannula or the transport tube described above, the locking key 144 willengage window 146 to couple the core cable to the implant. However, whenthe ocular implant is pushed distally beyond the distal tip of thecannula 108, as shown in FIG. 19, the implant can assume its pre-biasedconfiguration, causing the implant to expand and detach from the corecable.

The delivery devices described herein are configured to advance andretract an ocular implant and deliver the implant into the eye of apatient by a physician using a single hand. A physician typically hasonly one hand available to perform the implantation as the other hand isused to simultaneously hold and stabilize a gonioscope for visualizationof the implantation procedure. Physicians typically use their feetduring the procedure to adjust the image through the surgicalmicroscope, making a foot-operated system impractical.

As described above, advancement and retraction of the implant can becontrolled with a tracking wheel 106, and orientation of the implant inthe patient can be controlled by changing the orientation of thecannula, hub, implant, push tube, and core cable by rotating therotatable sleeve 104. When the ocular implant is advanced distallybeyond the distal tip of cannula 108, the implant can automaticallyexpand to a pre-biased configuration to disengage the push tube andremain within the patient in the desired location within the eye. Asdescribed above, it may be necessary to remove a core cable from withinthe implant by retracting the rotating rack gear in the proximaldirection before fully implanting the ocular implant in the patient.

FIGS. 20-22 illustrate a method for delivering an ocular implant into apatient. The ocular implant may be inserted into Schlemm's canal, thetrabecular meshwork, the suprachoroidal space, and/or the anteriorchamber to facilitate the outflow of aqueous humor from the anteriorchamber. This flow of aqueous humor can include axial flow alongSchlemm's canal, flow from the anterior chamber into Schlemm's canal,flow leaving Schlemm's canal via outlets communicating with Schlemm'scanal, or flow into the suprachoroidal space. When implanted within theeye, the ocular implant will support trabecular mesh tissue andSchlemm's canal tissue and will provide for improved communicationbetween the anterior chamber and Schlemm's canal (via the trabecularmeshwork), between pockets or compartments along Schlemm's canal, orbetween the anterior chamber and the suprachoroidal space.

FIG. 20 is a view showing a portion of the face and eye 20. Cannula 108extends through a cornea of eye 20 so that the distal end of cannula 108is disposed in the anterior chamber of the eye. With reference to FIG.20, it will be appreciated that the distal tip of cannula 108 ispositioned near the trabecular mesh and Schlemm's canal 32 of the eye.The orientation of the cannula to the eye can be adjusted by rotatingthe rotatable sleeve described above with reference to FIGS. 3-7.

FIG. 21 is a further enlarged view illustrating a portion of eye 20shown in the previous figure. In the embodiment of FIG. 21, the distaltip of cannula 108 has pierced through trabecular mesh 32. The distaltip of cannula 108 has also pierced the wall of Schlemm's canal 30 and adistal opening of cannula 108 is disposed in fluid communication withSchlemm's canal. In some embodiments, cannula 108 is curved to achievesubstantially tangential entry into Schlemm's canal.

FIG. 22 is an additional view of eye 20 shown in the previous figure. Inthe embodiment of FIG. 22, an ocular implant 122 has been advancedthrough the cannula and into Schlemm's canal of the eye. FIG. 22illustrates a core cable 124 disposed within the implant 122, and pushtube (not shown) abutting a proximal portion of the ocular implantwithin the cannula 108, as described above. The ocular implant can beadvanced through the delivery system and into the eye with the deliverydevice 100 described herein, such as by rotating tracking wheel 106 toadvance the push tube, core cable, and implant through the deliverysystem and into the eye, as described above with reference to FIGS. 3,6, and 12-13.

Once the implant is positioned within Schlemm's canal (or alternativelywithin the suprachoroidal space or other anatomy of the eye), theimplant can be advanced beyond a distal portion of the cannula to allowthe implant to detach from the push tube and core cable (as describedabove and shown in reference to FIGS. 14-19). The core cable can also beconfigured to automatically detach from the push tube, and the corecable can then be retracted from the ocular implant while the push tubeis allowed to abut the implant to keep the implant in place. Once theimplant is within the eye of the patient, the delivery system can beremoved from the patient leaving only the implant behind.

In another embodiment that does not utilize a push tube, as describedabove and referenced in FIGS. 18-19, the implant can be advanced beyonda distal portion of the cannula to allow the implant to detach from thea locking key of the core cable. The core cable can then be removed fromthe ocular implant. Once the implant is within the eye of the patient,the delivery system can be removed from the patient leaving only theimplant behind.

As for additional details pertinent to the present invention, materialsand manufacturing techniques may be employed as within the level ofthose with skill in the relevant art. The same may hold true withrespect to method-based aspects of the invention in terms of additionalacts commonly or logically employed. Also, it is contemplated that anyoptional feature of the inventive variations described may be set forthand claimed independently, or in combination with any one or more of thefeatures described herein. Likewise, reference to a singular item,includes the possibility that there are plural of the same itemspresent. More specifically, as used herein and in the appended claims,the singular forms “a,” “and,” “said,” and “the” include pluralreferents unless the context clearly dictates otherwise. It is furthernoted that the claims may be drafted to exclude any optional element. Assuch, this statement is intended to serve as antecedent basis for use ofsuch exclusive terminology as “solely,” “only” and the like inconnection with the recitation of claim elements, or use of a “negative”limitation. Unless defined otherwise herein, all technical andscientific terms used herein have the same meaning as commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs. The breadth of the present invention is not to be limited bythe subject specification, but rather only by the plain meaning of theclaim terms employed.

What is claimed is:
 1. A method of delivering an implant into an eye ofa patient, comprising: inserting a delivery device into the eye;advancing the implant into the eye through the delivery device; andexpanding the implant to disengage the implant from the delivery device.2. The method of claim 1 wherein the inserting step further comprisesinserting a cannula into Schlemm's canal of the eye.
 3. The method ofclaim 2 further comprising the step of adjusting an orientation of thecannula with an orientation mechanism to align the cannula with acurvature of Schlemm's canal.
 4. The method of claim 3 wherein theadvancing step and the adjusting step are achieved with a single-hand ofa user.
 5. The method of claim 1 wherein the advancing step furthercomprises advancing the implant with a wheel disposed on the deliverydevice.
 6. The method of claim 1 wherein the advancing step furthercomprises advancing the implant into the eye past a distal tip of thedelivery device.
 7. The method of claim 6 wherein the implantautomatically expands to disengage itself from the delivery device whenit is advanced past the distal tip of the delivery device.
 8. The methodof claim 1 wherein the expanding step further comprises expanding theimplant to disengage an interlocking component of the implant from aninterlocking component of the delivery device.
 9. The method of claim 8wherein the interlocking component of the delivery device is aninterlocking component of a push tube.
 10. The method of claim 8 whereinthe interlocking component of the delivery device is an interlockingcomponent of a core cable.
 11. The method of claim 1 wherein theadvancing step further comprises advancing the implant into the eye witha push tube.
 12. The method of claim 1 wherein the advancing stepfurther comprises advancing the implant into the eye with a core cable.13. The method of claim 12 further comprising removing the core cablefrom the implant after expanding the implant.
 14. The method of claim 1wherein the implant is inserted into a suprachoroidal space.
 15. Amethod of implanting an ocular implant into Schlemm's canal of an eye,comprising: rotating an orientation mechanism of a delivery device toalign a cannula with Schlemm's canal; advancing the cannula through acorneal incision and into the eye; piercing Schlemm's canal with thecannula; controlling an advancement mechanism of the delivery systemwith a first hand to advance the ocular implant from the delivery systeminto Schlemm's canal; holding a gonioscope with a second hand during thecontrolling step to visualize implantation of the ocular implant intoSchlemm's canal; and automatically disengaging the ocular implant fromthe delivery system when the ocular implant is advanced beyond a distaltip of the cannula.
 16. The method of claim 15 further comprisingexpanding the ocular implant in the eye to disengage the ocular implantfrom the delivery system.